A phase 2b, randomized, placebo-controlled, observer-blind study in adults 60 years of age and older to evaluate the efficacy, safety, and immunogenicity of a bivalent protein vaccine candidate against respiratory syncytial virus (RSV) and human metapneumovirus (HMPV)
NCT ID NCT07810010
First seen Sep 09, 2026 · Last updated Sep 09, 2026
Summary
Study VCA25397 is a Phase 2b, observer-blind, randomized, placebo-controlled, parallel, case-driven proof of concept study that will enroll approximately 8000 adults aged 60 years and older to assess the clinical efficacy, safety, and immunogenicity of a single IM (intramuscular) injection of the bivalent RSV+HMPV protein vaccine candidate. The study will include a Safety Lead-in Cohort that will be enrolled first and will comprise 200 participants aged 60 years and older randomized in a 1:1 ratio to receive either RSV+HMPV protein vaccine or placebo (100 participants per arm). The enrollment of the Main Cohort will start after the completion of the ESDR (Early Safety Data Review), pending a positive outcome. For the Main Cohort, 7800 participants (3900 participants per arm) will be randomized in a 1:1 ratio to receive either RSV+HMPV protein vaccine or placebo.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 8,000 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2026
An estimate. Start dates often move.
- Expected to finish
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Jul 2028
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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60 years and older
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Aged 60 years or older on the day of inclusion * Participants who, as determined by medical evaluation including medical history, physical examination, and clinical judgment of the Investigator are eligible for inclusion Exclusion Criteria: * Known/suspected immunodeficiency; immunosuppressive therapy/immunomodulators in past 6 months; long-term systemic corticosteroids (eg, prednisone for more than 2 weeks in past 3 months); history of immune-mediated neurological disease. Of note, persons living with stable HIV are not excluded * Known systemic hypersensitivity to any of the study intervention components or history of a life-threatening reaction to the study interventions used in the study or to a product containing any of the same substances * Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with study conduct or completion * Previous history of Guillain-Barré Syndrome (GBS) * Previous vaccination against RSV and/or HMPV (with a licensed or investigational vaccine either as a monovalent vaccine or any combination of the antigens) or previous receipt of RSV and/or HMPV monoclonal antibody The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The study's own enquiry address
This study publishes an address for enquiries. See it below .
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
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Contacts and locations
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Study contacts
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Contact
Email: •••••@•••••
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